Worldwide certification of quality systems at all manufacturing operations completed and GMP service for oligo drug development added
Integrated DNA Technologies (IDT), the world leader in oligonucleotide synthesis, has announced that the production processes for synthetic oligonucleotides at its European headquarters in Leuven, Belgium, have achieved ISO 9001:2008 certification.
All three IDT oligonucleotide facilities (Coralville, Iowa; San Diego, California; and Leuven, Belgium) now offer ISO 9001:2008 certification, with the Coralville manufacturing headquarters also providing ISO 13485:2003 certification for the manufacture of diagnostic oligonucleotides.
In addition, IDT’s Leuven facility will begin offering quality control and batch record services that are consistent with Good Manufacturing Practice (GMP) requirements associated with drug development activities.
'We are continually striving to provide the highest quality oligos as fast as possible to our customers, and this certification completes the company’s mission of having ISO 9001:2008 as a quality systems baseline for all of IDT’s manufacturing operations worldwide,' noted Rick McConahay, General Manager of IDT’s European Operations.
'It is also an important milestone for our European operation, which has experienced very rapid growth since its launch in the summer of 2008. It is a significant achievement to have grown from a simple start-up to making thousands of oligos per day, and in the process also implement and certify an ISO 9001:2008 compliant quality system.'
Certification followed an audit by BSI Management Systems, a prominent quality management systems registrar – requiring on-site assessments, examinations of IDT's documented procedures and an audit of overall operations. System quality and standards will subsequently be monitored by BSI Management Systems through periodic surveillance audits of IDT's processes.
The certification also marks IDT’s formal launch of a GMP analytical service for its oligo customers, who require GMP quality control and batch record services for their drug development activities. IDT has enhanced its analytical, batch recording and endotoxin testing capabilities, integrating these into the appropriate quality system infrastructure to deliver GMP solutions to its drug development customers.
With this additional service, IDT now offers oligonucleotides for all applications (research, diagnostic and therapeutic), at scales ranging from 25 nanomoles to 10 grams.